- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02879539
Cochlear Implant Low Power Strategy
July 2, 2021 updated by: The Hearing Cooperative Research Centre
Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors.
The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy.
However in order to develop smaller sound processors, further battery life power savings are required.
The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program.
In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use.
In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3002
- The HEARing CRC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult (>18 years) cochlear implant recipients
- Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
- User of commercially available Freedom, CP810 or CP900 series sound processor
- User of the ACE strategy or MP3000 strategy
- At least 3 months experience with the cochlear implant
- Native speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
Exclusion Criteria:
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MP3000-ACE strategy
MP3000 sound coding strategy or ACE strategy with lower stimulation rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Word recognition scores in quiet
Time Frame: Testing over 18 weeks
|
Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy
|
Testing over 18 weeks
|
Sentence recognition scores in quiet
Time Frame: Testing over 18 weeks
|
Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy
|
Testing over 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fundamental frequency (F0) discrimination
Time Frame: Testing over 18 weeks
|
F0 discrimination for MP3000 strategy compared to the ACE baseline
|
Testing over 18 weeks
|
Speech intelligibility and helpfulness subjective ratings
Time Frame: Testing over 18 weeks
|
For MP3000 strategy compared to the default ACE baseline
|
Testing over 18 weeks
|
Sentence in noise scores
Time Frame: Testing over 18 weeks
|
Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled.
|
Testing over 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2015
Primary Completion (Actual)
January 27, 2017
Study Completion (Actual)
January 27, 2017
Study Registration Dates
First Submitted
August 21, 2016
First Submitted That Met QC Criteria
August 21, 2016
First Posted (Estimate)
August 25, 2016
Study Record Updates
Last Update Posted (Actual)
July 6, 2021
Last Update Submitted That Met QC Criteria
July 2, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC5607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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